Various ambulatory medical devices are known for treating and/or monitoring patients at a remote site away from the caregiver's office. One example of an ambulatory medical device is a drug delivery device, such as a drug pump, for providing drug delivery to the patient when the patient is away from the caregiver's office.
Certain drugs rarely achieve their maximum therapeutic action through conventional injection techniques. Many drugs reach their full potential only through precise delivery over an extended period of time. With controlled drug infusion through a drug pump, the drug can be given at a precise rate that will keep the drug concentration within the therapeutic margin and out of the toxic range. Ambulatory drug pumps can provide appropriate drug delivery to the patient at a controllable rate which does not require frequent medical attention and which allows the patient to leave the hospital or caregiver's office.
Existing drug pumps are known to include a processor and an imbedded memory device for controlling operation of the pump. In addition, some pumps have various sensors, switches, and devices associated with the pumping operation of the pump.
There is a need for increased sophistication with respect to the drug therapies administered by the drug pumps in order to better treat patients and to reduce health care expenditures by reducing doctor visits and hospital stays.
Controlling operation of the drug pumps in sophisticated therapies is becoming an increasing concern. There is a need for some pumps to be used over a period of time for very different therapies, such as chemotherapy, pain control, nutrition, or antibiotic therapy, for the same or different patients. If the therapy type cannot be changed, or if the therapy type cannot be changed easily, the caregiver must maintain an inventory of pumps with each desired therapy type. Moreover, updates or changes in features of the therapies become a problem if the operating systems of the pumps cannot be changed or if the pumps are not easily changeable. Customization of the pumps is difficult or impossible.
Within each of the broad classes of therapies and other therapies, there are often patient specific parameters which need to be addressed. For example, some desired patient specific parameters may take into account such items as patient weight, and/or the severity of the patient's particular condition. One concern relates to whether and to what extent the pumps can be set for patient specific therapies.
If the pump therapy types and/or the patient specific parameters are changeable, there is a need for these changes to be easy for the caregiver to make. Further, if a problem in the pump operating system develops or if a change in the pump operating system needs to be made when the pump is away from the caregiver's office, this is a further concern.
Also, drug pumps must generally be reliable and durable in the settings in which they are used. Since the pumps are ambulatory, the patient may expose the pump to various environmental conditions and/or impurities that could damage fragile components of the pump. Failure of the drug pump to deliver the appropriate dosage of drug to the patient can be harmful to the patient.
There is a need for operating systems and methods for operating ambulatory medical devices, such as drug pumps, which address at least some of the needs and concerns noted above and other needs and concerns associated with the increasingly sophisticated and complex therapies and devices desired by the health care industry.